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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Bilayer Matrix Wound Dressing

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  Class 2 Device Recall Integra Bilayer Matrix Wound Dressing see related information
Date Initiated by Firm March 10, 2009
Date Posted April 07, 2009
Recall Status1 Terminated 3 on June 26, 2009
Recall Number Z-1174-2009
Recall Event ID 51402
510(K)Number K021792  
Product Classification Wound Dressing - Product Code FRO
Product Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not Re sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number BMW810.
Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536, USA.
Code Information Lot number 105BA0105205
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Jon Caparotta RAC
609-936-2495
Manufacturer Reason
for Recall		 Package Seal Integrity: Integra became aware of the potential of open seals in the foil pouch of the Integra Bilayer Matrix Wound Dressings.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Urgent: Product Recall Notification letters, dated March 10, 2009, were sent out by first class mail to all consignees. The letters asked consignees to quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and for arrangement of product returns. Consignees also need to complete and return the "Recall Acknowledgement and Return Form" indicating whether or not they possess any affected product. Additional questions should be directed to Judith O'Grady at 609-936-2311.
Quantity in Commerce 125 units
Distribution Nationwide Distribution -- including states of CA, FL, MN, TX, NC, GA, NY, OH, MI, NE, and PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRO and Original Applicant = INTEGRA LIFESCIENCES CORP.
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